44 % branched chain amino acids to counteract hepatic encephalopathy and to improve nutritional status1-4

Low in volume and sodium5 to counteract ascites and oedema6

With medium chain triglycerides (MCT) (35 % of fat) for easy absortion7

With fibre to maintain gut physiology8

Fresubin® HepaThe tailored solution for hepatic patients

1.3 kcal / mL tube feed for the dietary management of patients with or at risk of disease-related malnutrition, in particular liver failure or with risk of hepatic encephalopathy

(2750)

650 2087 23.5

KCAL

(kJ) PROTEIN (g)

LIPID (

g)CHO (g)Per 500 mL

For Health Care Professionals only.

Nutritional Information

Fresubin Hepa

Prescribing Information

Food for special medical purposes: Nutritionally complete, high-caloric (1.3 kcal / mL) tube feed with fibre; increased in branched chain amino acids and with medium chain triglycerides (MCT). Low in lactose and gluten. For the dietary management of patients with or at risk of disease-related malnutrition in particular with acute and chronic liver failure.

Dosage: To be determined by a health care professional ac cording to patients’ needs. Recommendation for complete nutrition ≥ 1.500 mL (1950 kcal) / day.

Important notes: To be used under medical supervision. Monitor feeding rate. Suitable as sole source of nutrition. Not suitable for infants < 1 year. Use with caution in children < 6 years. Not suitable for patients with galactosaemia. Ensure adequate fluid intake. Not for parenteral (I.V.) use.

Instructions for use: Recommended tube size: ≥ CH 5 for pump assisted feeding, ≥ CH 12 for gravity feeding. Store at room temperature. Once opened, use within 24 hours. Shake well before use! Do not use if bag is damaged or swollen or content is coagulated. Do not mix with drugs.

Contraindications: Not suitable whenever enteral nutrition is not permitted such as in acute gastrointestinal bleeding, ileus and shock. Use with caution in severe organ failure with impaired metabolism and severe forms of malassimilation. Not suitable for patients with congenital inability to metabolise nutrients contained in Fresubin Hepa.

Ingredients

Water, maltodextrin, vegetable oils (rapeseed oil, soya oil), medium chain triglycerides (MCT), soy protein, soy polysaccharides, milk protein, l-leucine, l-valine, l-arginine hydrochloride, potassium citrate, l-isoleucine, calcium phosphate, sodium citrate, magnesium citrate, choline chloride, vit. C, acidity regulator (E 330), magnesium oxide, calcium carbonate, thickener (E 407), iron sulphate, zinc sulphate, niacin, vit. E, manganese chloride, pantothenic acid, sodium fluoride, vit. B2, vit. B6, copper sulphate, vit. B1, vit. A, ß-carotene, folic acid, chromium chloride, sodium molybdate, potassium iodide, sodium selenite, biotin, vit. K1 , vit. D3, vit. B12.

Allergen Information: This product contains milk and soy.

Ready to use in 500 mL EasyBag

Average content 100 mL

Energy value kJ 550(= kcal) (130)

Fat (33% Energy) g 4.7 of which saturated fatty acids g 2.0 of which medium chain triglycerides g 1.7 of which monounsaturated fatty acids g 1.4 of which polyunsaturated fatty acids g 1.3Carbohydrate (53.5% Energy) g 17.4 of which sugars g 0.7 of which lactose g ≤ 0.01Fibre (1.5% Energy) g 1.0Protein (12% Energy) g 4.0 of which branched chain amino acids 44% g 1.93Salt (Na x 2.5) g 0.19Water mL 78Gluten ppm ≤ 20Lactose g ≤ 0.01 Osmolarity mosmol/l 330Osmolality mosmol/kg H2O 420Minerals and trace elementsSodium mg 75Chloride mg 71.5Potassium mg 120Calcium mg 80Phosphorus mg 53Magnesium mg 27Iron mg 1.33 Zinc mg 1.2Copper μg 130Iodine μg 13.3Selenium μg 6.67Manganese mg 0.27Chromium μg 6.67Molybdenum μg 10Fluoride mg 0.13Vitamins and other# substancesVitamin A μg RE° 92 of which ß-Carotene μg RE° 22Vitamin D3 μg 1.0Vitamin E mg α-TE°° 1.33Vitamin K1 μg 6.67Vitamin C mg 6.67Thiamin (vitamin B1) mg 0.13Riboflavin (vitamin B2) mg 0.17Vitamin B6 mg 0.16Niacin mg/mg NE°°° 1.6/2.3Folic Acid μg 27Vitamin B12 μg 0.27Pantothenic Acid mg 0.47Biotin μg 5.0Choline# mg 28

° retinol equivalents (RE), °° alpha-tocopherol equivalents (α-TE), °°° niacin equivalents (NE)

Fresenius Kabi Australia Pty LimitedLevel 2, 2 Woodland Way, Mount Kuring-gai NSW 2080Phone 1300 732 001Fax 1300 304 384www.fresenius-kabi.com.au

Fresenius Kabi New Zealand Limited 60 Pavilion Drive, MāngereAuckland 2022 New ZealandPhone 0800 144 892Fax +64 9925 2721PM2019.553V3 Pub: March 2021

References

1) Plauth M, Cabre E, Riggio O, et al. ESPEN guidelines on enteral nutrition: liver disease. Clin Nutr. 2006; 25(2): 285–294.

2) Amodio P, Bemeur C, Butterworth R, et al. The Nutritional Management of Hepatic Encephalopathy in Patients With Cirrhosis: International Society for Hepatic Encephalopathy and Nitrogen Metabolism Consensus. Hepatology. 2013; 58(1): 325–336.

3) Gluud LL, Dam G, Les I, et al. Branched-chain amino acids for people with hepatic encephalopathy. Cochrane Library. 2007. CD001939

4) Kawaguchi T, Taniguchi E, Sata M. Effects of oral branched-chain amino acids on hepatic encephalopathy and outcome in patients with liver cirrhosis. Nutrition in Clinical Practice. 2013; 28(5): 580–588.

5) Ginés P, Angeli P, Lenz K, et al. European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010; 53(3): 397–417.

6) Runyon BA. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009; 49(6): 2087–2107.

7) Babayan VK. Medium chain triglycerides and structured lipids. Lipids. 1987; 22(6): 417–420.

8) Lochs H, Allison SP, Meier R, et al. Introductory to the ESPEN Guidelines on Enteral Nutrition: terminology, definitions and general topics. Clin Nutr. 2006; 25(2): 180–186.